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Fusion Pharmaceuticals Reports Progress And Provides Recent Corporate Highlights

Benzinga · 01/06/2023 08:07

FPI-2068 IND expected to be submitted in the first quarter of 2023

FPI-1434 Phase 1 data expected in the second quarter of 2023

FPI-1966 Phase 1 study open and enrolling patients; Company expects to provide clinical data update in 2024

New actinium-225 partnership with BWXT Medical, a global leader in medical isotope supply, supports growing pipeline opportunities

HAMILTON, ON and BOSTON, Jan. 6, 2023 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today reported continued progress across its pipeline of target alpha therapies (TATs) and provided recent corporate highlights.

Fusion Chief Executive Officer John Valliant, Ph.D., commented, "With three Phase 1 clinical programs developing TATs as next-generation radiopharmaceuticals, Fusion is leading a wave of excitement in the radiopharmaceutical sector. Fusion is poised for an exciting year, with data from the Phase 1 study of FPI-1434 in solid tumors expressing IGF-1R expected in the second quarter. Additionally, we expect to file an investigational new drug application (IND) for FPI-2068, our first novel TAT being developed in collaboration with AstraZeneca, in the first quarter of 2023.

"While advancing our clinical programs, we've continued to focus on ensuring adequate actinium supply, and recently announced a new partnership with established global medical isotope supplier BWXT Medical. We are well positioned to execute on our clinical programs and continue to advance a diversified pipeline of cancer therapies generated through Fusion's internal R&D capabilities and technologies."

Portfolio Update

FPI-1434 

In the Phase 1 study, Fusion is exploring various dose levels of FPI-1434 as well as two dosing regimens: one with FPI-1434 alone, and another in which a small dose of cold antibody (naked IGF-1R antibody without the isotope) is administered prior to each dose of FPI-1434. The Company anticipates reporting safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, from the Phase 1 study in the second quarter of 2023. Fusion continues to anticipate the initiation of a Phase 1 combination study with FPI-1434 and KEYTRUDA® (pembrolizumab) to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.

FPI-1966

The Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3 is intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. Patient enrollment and dosing is ongoing. The first cohort of the Phase 1 portion of this study is designed to evaluate various doses of vofatamb ("cold antibody") to assess the impact of pre-dosing on tumor uptake and will inform the dosing regimen for the remainder of the study. The Company anticipates providing a clinical data update in 2024.

FPI-2068

Fusion and AstraZeneca are jointly developing FPI-2068, the first novel TAT created under the companies' multi-asset collaboration agreement. FPI-2068 utilizes Fusion's Fast-Clear™ linker technology to radiolabel an AstraZeneca bispecific antibody with actinium. The investigational new drug (IND) filing is expected to be submitted in the first quarter of 2023.